regulatory affairs officer

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Officer to join our team. This position is based in Athens, Kryoneri.

Main duties and responsibilities:

• Understanding of Regulatory strategy and documentation requirements.

• Act as responsible Regulatory Team member for assigned regulatory projects.

• Preparation of documentation for National phase of EU DCP/MRP/National procedures within assigned timelines. 

• Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.

• Liaise with external Regulatory authorities as required.

• Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.

• Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration.

• Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products.

• Preparation of submissions.

Requirements

Experience, skills and qualifications required:

• BSc Degree in Pharmacy, Biology or relevant field.

• 1-2 years of experience in Regulatory Affairs .

• Fluent in English and good MS Office skills.

• Strong organization skills, multi-tasking and able to meet deadlines.

• Effective communication and relationship management.

• Ability to work under pressure, resilience.

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.